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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to international guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
479-150-8
EC Name:
-
Cas Number:
7784-22-7
Molecular formula:
AlH6O6P3
IUPAC Name:
Phosphinic acid, aluminum salt (3:1)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Nature of substance: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
no
Amount / concentration applied:
100 MG
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #4
Remarks:
(mean score 4)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #5
Remarks:
(mean score 5)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #6
Remarks:
(mean score 6)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
(mean score 4)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
(mean score 5)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
(mean score 6)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
(mean score 4)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
(mean score 4)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
(mean score 5)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
(mean score 6)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(secretion)
Basis:
animal #4
Remarks:
(mean score 4)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(secretion)
Basis:
animal #5
Remarks:
(mean score 5)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(secretion)
Basis:
animal #6
Remarks:
(mean score 6)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
1-hour after application the following ocular reactions were observed: iritis grade 1 in 1/3 test eyes; redness grade 2 in 2/3 test eyes and grade 1 in 1/3 test eyes; chemosis grade 2 in 1/3 test eyes and grade 1 in 2/3 test eyes.

Secretion grade 1 to 2 was observed in 3/3 test eyes till
72-hour after application.

Fluorescein sodium dye detected treatment-related changes to
the surface of the cornea at the 24 and 48-hour time points
in 1/3 test eyes.

Blepharitis at 48-hour time point in 1/3 test eyes (one
rabbit). No additional ocular change was noted during the
observation period in 2/3 test eyes (other two rabbits).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
The substance Aluminium Hypophosphite was tested in vivo for eye irritation. No effect was recorded.